{
  "url": "https://openlegislation.uk/eu-directive-2004-73/annex-n7/division-B.31/division-3/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2004-73/annex-n7/division-B.31/division-3/division-1.json",
  "legislation": "eudr/2004/73",
  "legislation_title": "Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the twenty-ninth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2004-73",
  "path": "annex/n7/division/B.31/division/3/division/1",
  "kind": "division",
  "number": null,
  "heading": "TEST REPORT",
  "text": "The test report must include the following specific information:\nTest substance:\nphysical nature and, where relevant, physiochemical properties;\nidentification including CAS number if known/established;\npurity.\nVehicle (if appropriate):\njustification for choice of vehicle, if other than water.\nTest animals:\nspecies and strain used;\nnumber and age of animals;\nsource, housing conditions, diet, etc.;\nindividual weights of animals at the start of the test.\nTest conditions:\nrationale for dose level selection;\ndetails of test substance formulation/diet preparation, achieved concentration, stability and homogeneity of the preparation;\ndetails of the administration of the test substance;\nconversion from diet/drinking water test substance concentration (ppm) to the actual dose (mg/kg body weight/day), if applicable;\nenvironmental conditions;\ndetails of food and water quality.\nResults:\nMaternal toxic response data by dose, including but not limited to:\nthe number of animals at the start of the test, the number of animals surviving, the number pregnant, and the number aborting, number of animals delivering early;\nday of death during the study or whether animals survived to termination;\ndata from animals that do not survive to the scheduled kill should be reported but not included in the inter-group statistical comparisons;\nday of observation of each abnormal clinical sign and its subsequent course;\nbody weight, body weight change and gravid uterine weight, including, optionally, body weight change corrected for gravid uterine weight;\nfood consumption and, if measured, water consumption;\nnecropsy findings, including uterine weight;\nNOAEL values for maternal and developmental effects should be reported.\nDevelopmental endpoints by dose for litters with implants, including:\nnumber of corpora lutea;\nnumber of implantations, number and percent of live and dead foetuses and resorptions;\nnumber and percent of pre- and post-implantation losses.\nDevelopmental endpoints by dose for litters with live foetuses, including:\nnumber and percent of live offspring;\nsex ratio;\nfoetal body weight, preferably by sex and with sexes combined;\nexternal, soft tissue, and skeletal malformations and other relevant alterations;\ncriteria for categorisation if appropriate;\ntotal number and percent of foetuses and litters with any external, soft tissue, or skeletal alteration, as well as the types and incidences of individual anomalies and other relevant alterations.\nDiscussion of results.\nConclusions.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2004/73/annex/n7/division/B.31/division/3/division/1",
    "retrieved_at": "2026-11-01T15:22:47.605967+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}